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安罗替尼联合免疫检查点抑制剂及含铂化疗用于晚期非小细胞肺癌后线治疗的疗效和安全性:一项采用倾向评分匹配的回顾性三臂真实世界研究

Efficacy and safety of anlotinib combined with immune checkpoint inhibitors and platinum-containing chemotherapy for later-line advanced non-small cell lung cancer: a retrospective three-arm real-world study using propensity-score matching.

作者信息

Wang Zeyang, Ren Bingnan, Yang Haotian, Qiu Xuejia, Wu Yin, Xue Chaojun, Zhao Yue, Li Xiao, Yu Ze, Zhang Jinyuan

机构信息

Department of Oncology, Hebei General Hospital, Shijiazhuang, China.

Department of Pharmacy, Hebei General Hospital, Shijiazhuang, China.

出版信息

Front Oncol. 2024 Nov 25;14:1446950. doi: 10.3389/fonc.2024.1446950. eCollection 2024.

Abstract

OBJECTIVE

To assess the efficacy and safety of anlotinib combined with immune checkpoint inhibitors (ICIs) in patients with advanced non-small-cell lung cancer (NSCLC).

METHODS

Clinical data on patients with advanced NSCLC were collected from June 2019 to October 2022 at Hebei General Hospital, China. The efficacy and safety of anlotinib combined with ICIs and platinum-containing chemotherapy were retrospectively analyzed. The primary endpoint was progression-free survival (PFS). The secondary endpoint was the disease control rate (DCR) and overall survival (OS). Survival curves were created using the Kaplan-Meier method. The efficacy and adverse reactions were evaluated according to the RECIST 1.1 and CTCAE 5.0 standards.

RESULTS

A total of 54 patients were enrolled in this study after propensity score matching (PSM), including 27 men and 17 women, with a median age of 59. A total of 26 patients received anlotinib + ICIs + platinum-containing chemotherapy (AIC), 15 patients received anlotinib + platinum-containing chemotherapy (AC), and 13 patients received ICIs + platinum-containing chemotherapy (IC). The PFS of the AIC group was 7.76 months (95% CI: 3.71-NC). The DCR was 65.38%. The OS endpoint had not been reached, The AIC combination regimen group had a significantly longer PFS than the IC group (mPFS, 7.76 vs. 2.33 months, p=0.012, HR=0.23, 95% CI: 0.06-0.8). There was no significant difference in the DCR between the two groups (65.38% vs. 53.85%, p=0.326). There was a statistically significant difference in PFS between the AC group and the IC group (mPFS, 9.2 vs. 2.33 months, p=0.02, HR=0.14, 95% CI: 0.03-0.65). There was no significant difference in the DCR between the two groups (40% vs. 53.85%, p=0.445). The common adverse reactions of the combination of anti-angiogenic agents, ICIs, and platinum-containing chemotherapy were anemia (34.62%), allergic reactions (19.23%), thrombocytopenia (11.54%), gastrointestinal reactions (15.38%), and hepatobiliary disorders (11.54%). Most of them were manageable.

CONCLUSIONS

Anlotinib combined with immune checkpoint inhibitors and platinum-containing chemotherapy regimens offers a good survival benefit for patients with advanced non-small-cell lung cancer who fail to respond to standard therapy. When both efficacy and safety are considered, a combination of anti-angiogenic agents, ICIs, and platinum-containing chemotherapy can be used as a choice for the treatment of advanced NSCLC.

摘要

目的

评估安罗替尼联合免疫检查点抑制剂(ICI)治疗晚期非小细胞肺癌(NSCLC)患者的疗效和安全性。

方法

收集2019年6月至2022年10月在中国河北医科大学第一医院就诊的晚期NSCLC患者的临床资料。回顾性分析安罗替尼联合ICI和含铂化疗的疗效和安全性。主要终点为无进展生存期(PFS)。次要终点为疾病控制率(DCR)和总生存期(OS)。采用Kaplan-Meier法绘制生存曲线。根据RECIST 1.1和CTCAE 5.0标准评估疗效和不良反应。

结果

倾向评分匹配(PSM)后,本研究共纳入54例患者,其中男性27例,女性17例,中位年龄59岁。26例患者接受安罗替尼+ICI+含铂化疗(AIC),15例患者接受安罗替尼+含铂化疗(AC),13例患者接受ICI+含铂化疗(IC)。AIC组的PFS为7.76个月(95%CI:3.71-NC)。DCR为65.38%。OS终点未达到,AIC联合方案组的PFS显著长于IC组(mPFS,7.76个月对2.33个月,p=0.012,HR=0.23,95%CI:0.06-0.8)。两组DCR差异无统计学意义(65.38%对53.85%,p=0.326)。AC组和IC组的PFS差异有统计学意义(mPFS,9.2个月对2.33个月,p=0.02,HR=0.14,95%CI:0.03-0.65)。两组DCR差异无统计学意义(40%对53.85%,p=0.445)。抗血管生成药物、ICI和含铂化疗联合应用的常见不良反应为贫血(34.62%)、过敏反应(19.23%)、血小板减少(11.54%)、胃肠道反应(15.38%)和肝胆疾病(11.54%)。大多数不良反应可控制。

结论

对于对标准治疗无效的晚期非小细胞肺癌患者,安罗替尼联合免疫检查点抑制剂和含铂化疗方案可带来良好的生存获益。综合疗效和安全性考虑,抗血管生成药物、ICI和含铂化疗联合应用可作为晚期NSCLC的治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ea4/11625662/0f8a14fc0d40/fonc-14-1446950-g001.jpg

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